Your choice. Your birth control

About the patch

The patch can be placed on your upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. Do not place on your breasts or the same skin area as the previous patch. Only apply to clean, dry skin. Do not use lotions, creams, oils, powders, or makeup at the patch site. Check the patch every day to make sure all edges are sticking correctly. Your patch must stick securely to your skin to work properly. Do not try to reapply a patch if it is no longer sticky. Do not tape or wrap the patch to your skin. See how to apply it »

Where to apply your birth control
Where to apply your birth control

Size up the patch

Size comparison of the Xulane Patch
Size comparison of the Xulane Patch™
  • How does the patch work?

    Xulane is a birth control patch with two female hormones: an estrogen called ethinyl estradiol, and a progestin called norelgestromin. This type of combination hormonal contraception prevents pregnancy, and can be just as effective as the pill when used as directed. Your chance of getting pregnant depends on how well you follow the directions for using Xulane. The better you follow the directions, the less chance you have of getting pregnant.

    Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

    Hormones from the patch enter the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use the patch than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects, including blood clots. Please see the Important Safety Information below and click here for the full Patient information and Patient Instructions for Use.

  • How do I start the patch?

    If you are not currently using hormonal birth control, there are two options for starting the patch. Choose the option that is right for you:

    First day start

    Apply your first patch during the first 24 hours of your menstrual period.

    Sunday start

    Apply your first patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first patch that day, and no backup birth control is needed.

    If switching from the pill or vaginal contraceptive ring to the patch

    Complete your current pill cycle or vaginal ring cycle. Apply your first patch on the day you would normally start your next pill or insert your next vaginal ring. If you do not get your period within 1 week after taking your last active pill or removing your last vaginal ring, check with your healthcare provider to make sure you are not pregnant. You may still go ahead and start the patch for contraception. If you apply your patch more than 1 week after taking your last active pill or removing your last vaginal ring, use a non-hormonal contraceptive method with the patch for the first 7 days of patch use.

    If using after childbirth

    If you are not breastfeeding, wait 4 weeks before using the patch and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting the patch.

    If using after abortion or miscarriage

    You may start the patch immediately after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. You do not need to use another contraceptive method.

    If you do not start the patch within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start.You should follow the instructions above for First day start or Sunday start based on what's right for you, and read the full Patient Information for starting Xulane.

    If you are starting the patch after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using the patch and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting the patch.

  • How do I apply the patch?

    Use Xulane exactly as your healthcare provider tells you to use it. Place the patch on your upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. For example, you should not place it under the waistband of clothing. Do not place on your breasts, cut or irritated skin, or the same skin area as your last patch. Do not cut, damage, or alter the Xulane Patch in any way. Patch images shown below are for illustration purposes only and do not represent the actual Xulane® Patch.

    Before applying

    Make sure your skin is clean and dry. Don’t use lotions, creams, oils, powders, or makeup at the patch site. This may cause the patch to fail to stick properly or become loose.

    Applying the patch

    Applying the Xulane Patch™: Step 1

    Tear open the pouch at the top edge and one side edge. Peel open the foil pouch and gently remove the contents of the foil pouch and discard the additional pieces of film above and below the patch.

    Applying the Xulane Patch™: Step 2

    Peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.

    Applying the Xulane Patch™: Step 3

    Apply the sticky side of the patch on your clean, dry skin. Remove the other half of the clear plastic and attach the entire patch to your skin.

    Applying the Xulane Patch™: Step 4

    Press firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the patch.

    Check your patch every day to make sure all edges are sticking correctly.

  • When do I change it?

    Wear one Xulane Patch at a time. Make sure you remove your old patch before applying your new patch. Do not skip using any patches, even if you do not have sex often. Xulane is applied in a 4-week cycle:

    • Apply your patch one time each week for 3 weeks (21 total days).
    • Apply each new patch on the same day of the week. This day will be your “Patch Change Day.” For example, if you apply your first patch on a Monday, all of your patches should be applied on a Monday.
    • Do not apply your patch during week 4. Make sure you remove your old patch. This is your patch-free week. Your menstrual period should start during your patch-free week.
    • Begin a new 4-week cycle by applying a new patch on the day after week 4 ends. Repeat the cycle of 3 weekly applications followed by a patch-free week.
    • Your patch should never be off for more than 7 days in a row. If your patch is off for more than 7 days in a row and you have sex during this time, you could become pregnant.
    • If you miss a period you might be pregnant. Some women miss their periods or have light periods on hormonal birth control methods even when they are not pregnant. Call your healthcare provider if you miss one period and have not used your patch every day or you miss two periods in a row.

    To throw away the Xulane patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. Used Xulane patches should not be flushed in the toilet.

    If your patch becomes uncomfortable or your application site is red, painful, or swollen, remove your patch and apply a new patch to a new location until your next “Patch Change Day.”

    When to change your birth control
  • What if I forget to change it?

    If you forget to change or remove your patch…

    At the start of any patch cycle (Week 1, Day 1):

    You could become pregnant. You must use a backup contraception method for 7 days. Apply the first patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1.

    In the middle of your patch cycle (Week 2 or Week 3):

    If you forget to change your patch for 1 or 2 days, apply a new patch as soon as you remember. Apply your next patch on your normal “Patch Change Day.” No backup contraception method is needed.

    If you forget to change your patch for more than 2 days, you could become pregnant. Start a new 4-week cycle as soon as you remember by putting on a new patch. You now have a different “Patch Change Day” and a new Day 1. You must use a backup contraception method for the first 7 days of your new cycle.

    At the end of your patch cycle (Week 4):

    If you forget to remove your patch, take it off as soon as you remember. Start your next cycle on your normal “Patch Change Day,” the day after Day 28. No backup contraception method is needed.

    At the start of your next patch cycle:

    You could become pregnant. Apply the first patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1. Use a non-hormonal backup contraception method, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your new 4-week patch cycle.

    If you have trouble remembering to change your patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception.  

  • What if it becomes loose or falls off?

    Your patch must stick securely to your skin to work properly. Do not try to reapply the patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it. Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.

    If your patch edge lifts up:

    Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch. If your patch does not stick completely, remove it and apply a new patch. Do not tape or wrap the patch to your skin or reapply a patch that is partially stuck to clothing. 

    If your patch has been off or partially off:

    For less than 1 day, try to reapply it. If the patch does not stick completely, apply a new patch immediately. No backup contraception is needed and your “Patch Change Day” will stay the same.

    For more than 1 day or if you are not sure for how long, you could become pregnant. To reduce this chance, apply a new patch and start a new 4-week cycle. You will now have a new “Patch Change Day.” Use a non-hormonal backup contraception method, such as a condom and spermicide or diaphragm and spermicide, for the first week of your new 4-week patch cycle.

    If your patch becomes uncomfortable or your application site is red, painful or swollen:

    Change your patch. Remove your patch and apply a new patch to a new location until your next “Patch Change Day.”

 

INDICATION AND USAGE
  • Xulane® is a prescription contraceptive patch used for the prevention of pregnancy in women who choose to use a transdermal patch.

Limitation of Use:

  • Xulane may not be as effective in women weighing more than 198 lbs. (90 kg). If you weigh more than 198 lbs. (90 kg), talk to your healthcare professional about which method of birth control is right for you.

Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

IMPORTANT SAFETY INFORMATION

Boxed WARNING

What is the most important information I should know about Xulane?

Do not use Xulane if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control methods, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Women 15 to 44 years of age who use Xulane may have an increased risk of blood clots compared to women who use certain birth control pills.

You will be exposed to about 60% more estrogen if you use Xulane than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects, including blood clots.

See full Prescribing Information for complete Boxed WARNING.

What is Xulane? 

Xulane® is a prescription contraceptive patch used for the prevention of pregnancy in women who choose to use a transdermal patch.

Limitation of Use:

Xulane may not be as effective in women weighing more than 198 lbs (90 kg).

If you weigh more than 198 lbs. (90 kg), talk to your healthcare professional about which method of birth control is right for you.

Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

IMPORTANT SAFETY INFORMATION

Who should not use Xulane?

Do not use Xulane if you:

  • Smoke and are over 35 years old
  • Have or have had blood clots in your arms, legs, eyes or lungs
  • Have an inherited problem that makes your blood clot more than normal
  • Have had a stroke
  • Have had a heart attack
  • Have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
  • Have high blood pressure that medicine cannot control
  • Have diabetes with kidney, eye, nerve, or blood vessel damage
  • Have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35
  • Have liver disease, including liver tumors (benign or cancerous)
  • Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.  This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
  • Have unexplained vaginal bleeding
  • Are pregnant or think you may be pregnant. However, Xulane is not known to cause birth defects when used by accident during pregnancy.
  • Have had breast cancer or any cancer that is sensitive to female hormones

Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.

Tell your healthcare professional if you have ever had any of the above conditions. Your healthcare professional may recommend another method of birth control.

Before you use Xulane tell your healthcare professional:

  • About all your medical conditions.
  • If you are pregnant or think you are pregnant.
  • If you are scheduled for surgery. Xulane may increase your risk of blood clots after surgery. You should stop using your Xulane patch at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
  • If you are or will be inactive or immobilized for a long period of time.
  • If you are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods.
  • Are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like Xulane, may decrease the amount of milk you make. A small amount of hormones from the Xulane patch may pass into your breast milk. Consider another method of birth control until you are ready to stop breastfeeding.

Tell your healthcare professional about all medicines and herbal products that you take.

Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

  • certain seizure medicines (carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, and topiramate)
  • aprepitant
  • barbiturates
  • bosentan
  • griseofulvin
  • certain combinations of HIV medicines (nelfinavir, ritonavir, ritonavir-boosted protease inhibitors)
  • certain non-nucleoside reverse transcriptase inhibitors (nevirapine)
  • rifampin and rifabutin
  • St. John’s wort

Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make the Xulane patch less effective.

Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together, including:

  • acetaminophen
  • ascorbic acid
  • medicines that affect how your liver breaks down other medicines (itraconazole, ketoconazole, voriconazole, and fluconazole)
  • certain HIV medicines (atazanavir, indinavir)
  • atorvastatin
  • rosuvastatin
  • etravirine

Hormonal birth control methods may interact with lamotrigine, an anti-seizure medicine used for epilepsy. This may increase the risk of seizures, so your healthcare professional may need to adjust the dose of lamotrigine.

Women on thyroid replacement therapy may need increased doses of thyroid hormone.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

 

What are the possible side effects of Xulane?

Xulane may cause serious side effects, including:

  • Blood clots. Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using hormonal birth control and when you restart the same or different hormonal birth control after not using it for a month or more. Some studies have reported that women who use norelgestromin and ethinyl estradiol transdermal system have a higher risk of getting a blood clot. Talk with your healthcare professional about your risk of getting a blood clot before using Xulane or deciding which type of birth control is right for you.

It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

  • legs (deep vein thrombosis)
  • lungs (pulmonary embolus)
  • eyes (loss of eyesight)
  • heart (heart attack)
  • brain (stroke)

Call your healthcare professional right away if you have:

  • leg pain that will not go away
  • sudden shortness of breath
  • sudden blindness, partial or complete
  • severe pain or pressure in your chest
  • sudden, severe headache unlike your usual headaches
  • weakness or numbness in an arm or leg, or trouble speaking
  • yellowing of the skin or eyeballs

Other serious risks include:

  • liver problems including liver tumors
  • gallbladder disease
  • high blood pressure

The most common side effects of Xulane are:

  • breast symptoms (discomfort, swelling, or pain)
  • nausea
  • headache
  • skin irritation, redness, pain, swelling, itching or rash at the patch application site
  • stomach pain
  • pain during menstruation
  • vaginal bleeding and menstrual disorders, such as spotting or bleeding between periods
  • mood, affect and anxiety disorders

Some women have spotting or light bleeding, breast tenderness, or feel sick to their stomach during norelgestromin and ethinyl estradiol transdermal system use. If these symptoms occur, do not stop using the Xulane patch. The problem will usually go away. If it doesn't go away, check with your healthcare professional.

Less common side effects are:

  • acne
  • less sexual desire
  • bloating or fluid retention
  • blotchy darkening of your skin, especially your face
  • high blood sugar, especially in women with diabetes
  • high fat (cholesterol, triglycerides) levels in the blood
  • depression, especially if you have had depression in the past. Call your healthcare professional immediately if you have any thoughts of harming yourself.
  • problems tolerating contact lenses
  • weight gain

Tell your healthcare professional about any side effect that bothers you or that does not go away. These are not all the possible side effects of Xulane. For more information, ask your healthcare professional or pharmacist.

What should I know about my period when using Xulane?

  • When you use Xulane, you may have bleeding and spotting between periods called unplanned bleeding. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using the patch on schedule. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare professional.

What if I miss my scheduled period when using Xulane?

  • Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your patches correctly, or you have symptoms associated with pregnancy, such as morning sickness or unusual breast tenderness, call your healthcare professional because you may be pregnant. Stop taking Xulane if you are pregnant.

How do I use Xulane after childbirth?

  • If you are not breastfeeding, wait 4 weeks before using Xulane and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting Xulane.

How do I use Xulane after childbirth?

  • If you are not breastfeeding, wait 4 weeks before using Xulane and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting Xulane.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This is not all of the information you should read prior to using Xulane. Please click here to see Patient Information and full Prescribing Information.

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IMPORTANT SAFETY INFORMATION Prescribing Information

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL

Cigarette Smoking and Serious Cardiovascular Risks
Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use.

IMPORTANT SAFETY INFORMATION Prescribing Information

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL

Cigarette Smoking and Serious Cardiovascular Risks
Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including Xulane, should not be used by women who are over 35 years of age and smoke.

Risk of Venous Thromboembolism
The risk of venous thromboembolism (VTE) among women aged 15 to 44 who used the norelgestromin and ethinyl estradiol transdermal system compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of norelgestromin and ethinyl estradiol transdermal system.

Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)
The PK profile for norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css) for EE are approximately 60% higher in women using norelgestromin and ethinyl estradiol transdermal system compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using norelgestromin and ethinyl estradiol transdermal system. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using norelgestromin and ethinyl estradiol transdermal system compared with women using oral contraceptives containing 30 mcg to 35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE.

CONTRAINDICATIONS
Do not prescribe Xulane to women who are known to have the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
    • -Smoke, if over age 35
    • -Have deep vein thrombosis or pulmonary embolism, now or in the past
    • -Have inherited or acquired hypercoagulopathies
    • -Have cerebrovascular disease
    • -Have coronary artery disease
    • -Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
    • -Have uncontrolled hypertension
    • -Have diabetes mellitus with vascular disease
    • -Have headaches with focal neurological symptoms or have migraine headaches with aura
    • Women over age 35 with any migraine headaches
  • Liver tumors, benign or malignant, or liver disease
  • Undiagnosed abnormal uterine bleeding
  • Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • Do not prescribe Xulane to women using Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems
Stop Xulane if an arterial or deep venous thrombotic event (VTE) occurs.

Stop Xulane if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

If feasible, stop Xulane at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of Xulane during prolonged immobilization and resume treatment based on clinical judgment.

Start Xulane no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

The use of combination hormonal contraceptives (CHCs) increases the risk of VTE. Known risk factors for VTE include smoking, obesity and family history of VTE, in addition to other factors that contraindicate use of CHCs.

Some of the data from the epidemiologic studies suggest an increased risk of VTE with use of norelgestromin and ethinyl estradiol transdermal system compared to use of some combined oral contraceptives. The interpretations of relative risk estimates from these studies range from no increase in risk to an approximate doubling of risk. One of the studies found a statistically significant increased risk of VTE for current users of norelgestromin and ethinyl estradiol transdermal system.

An increased risk of thromboembolic and thrombotic disease associated with the use of combination hormonal contraceptives (CHCs) is well established. Although the absolute VTE rates are increased for users of CHCs compared to non-users, the rates associated with pregnancy are even greater, especially during the post-partum period.

The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 woman-years.

The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to CHCs gradually disappears after CHC use is discontinued.

To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE.

Use of CHCs also increases the risk of arterial thromboses such as, cerebrovascular events (thrombotic and hemorrhagic strokes) and myocardial infarctions, especially in women with other risk factors for these events. In general, the risk is greatest among older (> 35 years of age), hypertensive women who also smoke. Use CHCs with caution in women with cardiovascular disease risk factors.

PK Profile of Ethinyl Estradiol

The PK profile for norelgestromin and ethinyl estradiol transdermal system patch is different from the PK profile for oral contraceptives in that it has a higher Css and a lower Cmax. AUC and average Css for EE are approximately 60% higher in women using norelgestromin and ethinyl estradiol transdermal system compared with women using an oral contraceptive containing EE 35 mcg. In contrast, the Cmax for EE is approximately 25% lower in women using norelgestromin and ethinyl estradiol transdermal system. Inter-subject variability results in increased exposure to EE in some women using either norelgestromin and ethinyl estradiol transdermal system or oral contraceptives. However, inter-subject variability in women using norelgestromin and ethinyl estradiol transdermal system is higher. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using norelgestromin and ethinyl estradiol transdermal system compared with women using oral contraceptives containing 30 mcg to 35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism.

Liver Disease

Do not use Xulane in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver. Discontinue Xulane if jaundice develops. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal and CHC causation has been excluded.

Xulane is contraindicated in women with benign and malignant liver tumors. Hepatic adenomas are associated with CHC use. An estimate of the attributable risk is 3.3 cases/100,000 CHC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) CHC users. However, the risk of liver cancers in CHC users is less than one case per million users.

Risk of liver enzyme elevations with concomitant hepatitis C treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal, were significantly more frequent in women using ethinyl estradiol-containing medications. Discontinue Xulane prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Xulane can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

High Blood Pressure

Xulane is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, monitor blood pressure and stop Xulane if blood pressure rises significantly. An increase in blood pressure has been reported in women taking hormonal contraceptives, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis.

Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who take Xulane. CHCs may decrease glucose tolerance in a dose-related fashion. In a 6-cycle clinical trial with norelgestromin and ethinyl estradiol transdermal system there were no clinically significant changes in fasting blood glucose from baseline to end of treatment.

Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on hormonal contraceptives.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using hormonal contraceptives.

Headache

If a woman taking Xulane develops new headaches that are recurrent, persistent or severe, evaluate the cause and discontinue Xulane if indicated. Consider discontinuation of Xulane in the case of increased frequency or severity of migraine during hormonal contraceptive use (which may be prodromal of a cerebrovascular event).

Bleeding Irregularities

Unscheduled (breakthrough) bleeding and spotting sometimes occur in women using norelgestromin and ethinyl estradiol transdermal system. Consider non-hormonal causes and take adequate diagnostic measures to rule out malignancy, other pathology, or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology and pregnancy have been excluded, time or a change to another contraceptive product may resolve the bleeding.

In the event of amenorrhea, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one patch or started the patch on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Some women may encounter amenorrhea or oligomenorrhea after discontinuation of hormonal contraceptive use, especially when such a condition was pre-existent.

Hormonal Contraceptive Use Before or During Early Pregnancy

Discontinue Xulane use if pregnancy is confirmed. Administration of CHCs should not be used as a test for pregnancy.

Depression

Carefully observe women with a history of depression and discontinue Xulane if depression recurs to a serious degree.

Carcinoma of Breasts and Cervix

Xulane is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormonally sensitive. There is substantial evidence that CHCs do not increase the incidence of breast cancer. Although some past studies have suggested that CHCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that combination oral contraceptive use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

Effect on Binding Globulins

The estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.

Monitoring

A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

Hereditary Angioedema

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Chloasma

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using Xulane.

Adverse Reactions

The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the Important Safety Information:

  • Serious cardiovascular events and stroke
  • Vascular events, including venous and arterial thromboembolic events
  • Liver disease

Adverse reactions commonly reported by users of combination hormonal contraceptives are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

The most common adverse reactions (≥ 5%) reported during clinical trials of norelgestromin and ethinyl estradiol transdermal system were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability.

Additional adverse drug reactions that occurred in < 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in the clinical trials are:

  • Abdominal distension
  • Fluid retention1, malaise
  • Cholecystitis
  • Blood pressure increased, lipid disorders1
  • Muscle spasms
  • Insomnia, libido decreased, libido increased
  • Galactorrhea, genital discharge, premenstrual syndrome, uterine spasm, vaginal discharge, vulvovaginal dryness
  • Pulmonary embolism
  • Chloasma, dermatitis contact, erythema, skin irritation

1Represents a bundle of similar terms

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Coadministration of atorvastatin or rosuvastatin and certain CHCs containing EE increase AUC values for EE by approximately 20% to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of coadministration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of CHCs.

Do not co-administer Xulane with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations.

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

Use In Specific Populations

Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion.

The effects of Xulane in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

Safety and efficacy of norelgestromin and ethinyl estradiol transdermal system have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.

Xulane has not been studied in postmenopausal women and is not indicated in this population.

No studies with Xulane have been conducted in women with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptive use until markers of liver function return to normal and combined hormonal contraceptive causation has been excluded.

No studies with Xulane have been conducted in women with renal impairment.

Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.

This is not all of the information you should read prior to prescribing Xulane. Please click here to see Patient Information and full Prescribing Information.

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